Philips Ultrasound, LLC recalls Philips Lumify Diagnostic Ultrasound System
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital…
Read the official notice →- Date
- 2026-10-28
- Country
- United States
- Brand
- Philips Ultrasound
- Product
- Philips Lumify Diagnostic Ultrasound System
- Classification
- Class I
- Units
- Worldwide - US Nationwide distribution including in the states of CA, MA, IL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Ultrasound recalls
- 2026-09-30
Philips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
FDA · DevicePhilips Ultrasound, LLCWorldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA,…Official notice →- 2026-04-01
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-01-07
Philips Ultrasound, LLC recalls Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232,…
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
FDA · DevicePhilips Ultrasound, LLCWorldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →- 2025-12-10
Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
FDA · DevicePhilips Ultrasound, LLCWorldwide US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-09-03
Philips Ultrasound, Inc recalls TRANSDUCER L12-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-07-09
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
FDA · DevicePhilips Ultrasound, IncDomestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-28
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Potential for leakage and backflow at the Safsite valve.
FDA · DeviceB Braun Medical IncWorldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN,…Official notice →Think Surgical, Inc. recalls Think Surgical Square Driver REF: 109126
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
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Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Ventec Life Systems, Inc. recalls VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
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Microbial Contamination of Sterile Products
Par Health USA, LLC recalls Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA…
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.